D-39740-2011. Next-generation LED phototherapy NanoBlu 500



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Transcription:

D-39740-2011 Next-generation LED phototherapy NanoBlu 500

02 Is there a powerful phototherapy device that s really compact? D-3534-2011

03 BETTER TREaTMENTS SuPPoRT BETTER outcomes The effective treatment of hyperbilirubinemia (jaundice) is crucial to newborn health. Some 60% of normal newborns become clinically jaundiced sometime during the first week of life. 1 If not treated in time, jaundice can cause severe physical damage to the child. In effect, the better the jaundice treatment, the better the outcome. NEXT-GENERaTIoN LED PHoToTHERaPY At Dräger, our focus on minimal stress therapies has led to the development of jaundice screening and therapeutic solutions that are non-invasive, simple-to-use, and highly effective. Designed to meet AAP guidelines for intensive phototherapy, the Dräger NanoBlu 500 is a compact, powerful phototherapy unit for the treatment of hyperbilirubinemia in newborn infants. With light-emitting diodes (LEDs) that emit blue light in the 400-550 nm spectrum, NanoBlu 500 is aligned with the peak absorption wavelength (450 nm) at which bilirubin is broken down. 2 EaSY on THE BaBY, EMPoWERING FoR THE CaREGIVER Innovative technology enables the NanoBlu 500 to evenly distribute high irradiance with only five LEDs and you can adjust irradiance levels for the specific needs of each infant. An optional integrated radiometer with optical sensor enables you to regularly monitor the light intensity of the phototherapy as recommended by most hospital protocols. In addition, you can automatically document irradiance measurements and download that information to a computer and/or printer for a more complete record. 1 Maisels, M.J. and McDonagh, A.F. Phototherapy for Neonatal Jaundice. New England Journal of Medicine, volume 358, number 9, February 28, 2008, pages 920-928. 2 Vreman HJ, et al. Light-emitting diodes: a novel light source for phototherapy. Pediatric Research. 1998; 44(5):804-809.

4 Customizable & connected phototherapy Control & Innovation Control specific irradiance level from 10 to 100%: allows you to accurately match your hospital protocol requirements Access full menu from one interface: provides fast access to device settings, maintenance and calibration, time and calendar, device usage data Generate reports containing hour counter, time of exposure, calendar/clock, and stored irradiance files: lets you document the performance of the phototherapy session Effective application High intensity levels Provides optimal spectrum levels Distributes light uniformly across body of infant Does not require touching the baby or placing an additional device directly in their proximity, which is important for very low birth weight infants D-46228-2012 Practicality Trolley or hood-mount option adds flexibility to the work space around the baby Highly flexible and adjustable positioning on babies in incubators or warmers Optional integrated radiometer with optical sensor to ensure optimal performance Long-lasting LED technology and low power consumption compared to fluorescent lights

5 Dräger NanoBlu 500 is the first line of defense for the effective treatment of jaundice. It delivers the key criteria for effective phototherapy: the right spectrum of light, at the right intensity, to as much of the baby s skin as possible in a compact, easyto-use package. 50 cm (19.69 ) 40 cm (15.75 ) 30 cm (11.81 ) 14 cm (5.51 ) 45-65 µw/cm 2 -nm 16 cm (6.3 ) 30-45 µw/cm 2 -nm 18 cm (7.09 ) 20-30 µw/cm 2 -nm The Dräger NanoBlu 500 includes five LEDs that provide a high level of blue-spectrum light. They are composed of an Indium and Gallium Nitride (InGaN) semiconductor structure, which enables the use of fewer LEDs and eliminates ultraviolet and infrared filters. The light provides a large ellipse of medium-intensity light coverage, allowing for more light to reach the infant.

6 TECHNICaL DaTa Device classification Protection class of trolley mount Class I, continuous operation equipment without applied parts Protection class of hood mount Class II, continuous operation equipment without applied parts Ingress of liquids IPX0, regular equipment - not waterproof Classification in accordance with EU Directive Device class IIa 93/42/EEC Appendix IX UMDNS code/gmdn code 17516/34477 Power Requirements 100 V~ to 240 V~, 50/60 Hz, 50 VA, 1.5 A Physical specifications Dräger nanoblu 500 hood Mount Width Depth Height Net weight Weight when packaged 11.6 cm (4.57 in) 23.0 cm (9.06 in) 5.0 cm (1.97 in) 1.0 kg (2.2 lb) 3.0 kg (6.6 lb) Dräger nanoblu 500 trolley Mount Width Depth Height Net weight Weight when packaged 50.0 cm (19.69 in) 50.0 cm (19.69 in) 100.0 cm to 140.0 cm (39.37 in to 55.12 in) 9.0 kg (19.8 lb) 14.0 kg (30.9 lb) irradiance at 30 cm (11.81 in) Illuminated area fulcrum Minimum 40 μw/cm 2 nm (+10 %) Illuminated area dimensions 40 cm by 37 cm (15.75 in by 14.57 in) Irradiance adjustment band 10 % to 100 % of maximum irradiance (+10 %) Irradiance adjustment increment at every 10 % optical sensor/radiometer Measurement band Resolution Reading accuracy 0 μw/cm 2 nm to 200 μw/cm 2 nm 0.1 μw/cm 2 nm ±2 μw/cm 2 nm Noise < 52 dba electrical specifications Power Supply Output voltage Output power Input voltage Operating frequency Universal input power supply 12 VDC 50 W 120-240 VAC 50/60 Hz

7 environmental RequiReMents temperature range Operating Storage 18 to 28 C (64.4 to 82.4 F) -20 to 60 C (-4 to 140 F) Relative humidity Operating Storage 10 % to 95 % (non condensing) 10 % to 95 % (non condensing) atmospheric Pressure Operating Storage 700 hpa to 1060 hpa 500 hpa to 1060 hpa Data transmission RS-232 serial port Standard UART protocol Bits per second 9600 bps Data bits 8 Parity None Stop bits 1 Flow control None standards IEC60601-1:1988 Medical Electrical Equipment, Part 1: General Requirements for Safety UL60601-1 1st Edition, 2006 Medical Electrical Equipment, Part 1: General Requirements for Safety CAN/CSA-C22.2 No. 601.1-M90, 2005 IEC60601-2-50:2000 Medical Electrical Equipment, Part 2: Particular requirements for the safety of infant phototherapy equipment IEC 60601-1-2:2001 Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests NanoBlu 500 offers a variety of mounting options.

Corporate headquarters Drägerwerk AG & Co. KGaA Moislinger Allee 53 55 23558 Lübeck, Germany www.draeger.com USA Draeger Medical, Inc. 3135 Quarry Road Telford, PA 18969-1042, USA Tel +1 215 721 5400 Toll-free +1 800 437 2437 Fax +1 215 723 5935 info.usa@draeger.com CANADA Draeger Medical Canada Inc. 120 East Beaver Creek Road Suite 104 Richmond Hill Ontario L4B 4V1, Canada Tel +1 905 763 3702 Toll-free +1 866 343 2273 Fax +1 905 763 1890 Canada.Support@draeger.com Manufactured for: Draeger Medical Systems, Inc. Telford, PA 18969, USA The quality management system at Draeger Medical Systems, Inc. is certified according to ISO 13485 and ISO 9001. 90 67 254 03.12-2 Marketing Communications SL Neo Printed in the United States Chlorine-free environmentally compatible Subject to modifications 2012 Drägerwerk AG & Co. KGaA